South Australian Consolidated Regulations South Australian Consolidated RegulationsSchedule—Reproductive Technology Code of Ethical Clinical Practice
Part
1—Preliminary
This code may be cited as the Reproductive Technology Code of Ethical Clinical
Practice 1995 .
In this code, unless the contrary intention appears—
Act means the Reproductive Technology (Clinical Practices) Act 1988 ;
artificial insemination by donor means an artificial fertilisation procedure
(not being an in vitro fertilisation procedure or a surgical procedure) under
which donor sperm are introduced, by artificial means, into the reproductive
system of a woman;
the Council means the South Australian Council on Reproductive Technology
established by Part 2 of the Act;
counselling means a process of information sharing, decision-making or therapy
that takes place during structured conversations between a counsellor and his
or her client;
counsellor means a social worker, nurse or clinical psychologist who—
(a) has
professional knowledge in the fields of human fertility and infertility and
reproductive technology; or
(b) has
had experience working in a reproductive medicine unit where infertility
treatment is given pursuant to a licence or exemption under this Act or
pursuant to an authority granted under a law of another State, or a Territory,
of the Commonwealth;
embryo means a human embryo within the meaning of the
Prohibition of Human Cloning Act 2003 ;
embryo flushing means a surgical procedure by which an ovum in the process of
fertilisation, or an embryo, is flushed from the body of a woman before it has
implanted in her uterus;
embryologist means a person who—
(a)
—
(i)
is a medical practitioner; or
(ii)
has qualifications in biological sciences; and
(b) is
in charge of embryology in a reproductive medicine unit;
Fertility Society Code of Practice means the Code of Practice for Units Using
In Vitro Fertilisation and Related Reproductive Technologies prepared by the
Reproductive Technology Accreditation Committee of the Fertility Society of
Australia, as in force from time to time;
Fertility Society donor screening guidelines means the guidelines for the
screening of donors of reproductive material contained in the Fertility
Society Code of Practice;
gamete intra fallopian transfer means an artificial fertilisation procedure
(not being an in vitro fertilisation procedure) by which sperm and ova are
placed, by artificial means, directly into a fallopian tube of a woman;
identifying information , in relation to a person, means the person's name or
address;
infertility treatment means treatment for human infertility involving the
application of an artificial fertilisation procedure;
licensee means—
(a) a
person who holds a licence under section 13(1) of the Act; or
(b) a
registered medical practitioner to whom an exemption under section 13(7) of
the Act applies;
married couple includes two people who are not married but who are cohabiting
as husband and wife and who—
(a) have
cohabited continuously as husband and wife for the immediately preceding five
years; or
(b)
have, during the immediately preceding six years, cohabited as husband and
wife, for periods aggregating at least five years,
and husband , wife and spouse have corresponding meanings;
medical practitioner means—
(a) a
person who is registered on the general register under the Medical
Practitioners Act 1983 ; or
(b) a
person registered as a medical practitioner under the law of another State, or
a Territory, of the Commonwealth;
NHMRC means the National Health and Medical Research Council established by
the National Health and Medical Research Council Act 1992 of the
Commonwealth;
nurse means a person registered under the Nurses Act 1984 ;
ovum means a human ovum;
psychologist means—
(a) a
person registered as a psychologist under the Psychological
Practices Act 1973 ; or
(b) a
person registered as a psychologist under the law of another State, or a
Territory, of the Commonwealth;
reproductive material means human reproductive material;
reproductive medicine unit means a hospital, clinic or other premises, or any
particular part of such a place, at which infertility treatment is given;
semen means human semen;
social worker means a person who holds a tertiary qualification in social
work;
sperm means human sperm;
storage , in relation to reproductive material, means storage outside the
human body;
treatment includes—
(a) all
medical or surgical advice, attendances, procedures, operations and other
services carried out by a medical practitioner in the course of medical or
surgical practice; and
(b) the
prescription or supply of drugs.
2A—Compliance with NHMRC guidelines
Any clinical practice involving human reproductive material must be undertaken
in compliance with the relevant requirements of the Ethical Guidelines on the
Use of Reproductive Technology in Clinical Practice and Research published by
the NHMRC.
Part 2—Prohibited practices
4—Prohibition on culturing or maintaining embryo outside body
A licensee must not maintain an embryo, or cause, suffer or permit an embryo
to be maintained, outside the human body for more than 10 years after
fertilisation.
5—Prohibition on transfer of more than three embryos or ova in one cycle
A licensee must not place, or cause, suffer or permit to be placed, more than
three embryos or three ova in the reproductive system of a woman in any one
cycle of infertility treatment.
6—Prohibition on mixing of gametes or embryos from different sources
A licensee must not, in the same artificial fertilisation procedure, do, or
cause, suffer or permit to be done, any of the following things:
(a) the
mixing of ova with sperm produced by more than one man; or
(b) the
mixing of sperm with ova produced by more than one woman; or
(c) the
mixing of embryos other than those resulting from fertilisation of ova
produced by the one woman by sperm produced by the one man.
7—Prohibition on use of donor gametes in certain cases
(1) A licensee must
not, in any infertility treatment, use, or cause, suffer or permit to be used,
the reproductive material of a donor if the licensee knows or has reason to
believe that the donor was, or may have been, at the time of donation,
suffering from an illness, disease or genetic defect or trait for which
screening is recommended by the Fertility Society donor screening guidelines.
(2) A licensee must
not, in any infertility treatment, use, or cause, suffer, or permit to be
used, the reproductive material of a donor if, in this State, 10 children have
been born alive in consequence of infertility treatment using reproductive
material of that donor unless—
(a) the
material is to be used for the benefit of a married couple who have already
had a child in consequence of the use of that donor's material; and
(b) the
couple have requested in writing that the material of that donor be used for
the purpose of conceiving another child.
8—Prohibition on use of gametes of close family members of recipients
A licensee, in giving infertility treatment to a married couple—
(a) must
not, if the wife's ova are to be used in the treatment, use, or cause, suffer
or permit to be used, sperm from the wife's father, son, brother or
half-brother; and
(b) must
not, if the husband's sperm are to be used in the treatment, use, or cause,
suffer or permit to be used, the ova of the husband's mother, daughter, sister
or half-sister.
9—Prohibition on use of embryos used in research
A licensee must not, in giving infertility treatment to a married couple, use,
or cause, suffer or permit to be used, an embryo that has been used in
research unless the licensee is of the opinion, after consultation with an
embryologist, that there is a reasonable expectation of that embryo implanting
and developing normally.
Part 3—Eligibility for infertility treatment and gamete donation
11—Eligibility for infertility treatment
(1) A licensee must
not give infertility treatment, or cause, suffer or permit infertility
treatment to be given, to a married couple unless the licensee has been
furnished with—
(a)
—
(i)
a certified copy under seal of the couple's certificate
of marriage; or
(ii)
if the couple is not married but is cohabitating as
husband and wife, a statutory declaration, signed by both spouses, setting out
the period or periods of their cohabitation; and
(b) a
letter of referral signed by a medical practitioner—
(i)
—
(A) stating that the wife has been unable
to conceive a child naturally and that the couple has undergone assessment or
received preliminary treatment for infertility; or
(B) stating that, in his or her opinion,
there is a risk that a genetic defect would be transmitted to any child
conceived naturally by the wife and specifying the nature of that defect; and
(ii)
stating that, in his or her opinion, neither spouse is,
as at the date of the signing of the letter, suffering from any illness,
disease or disability that would, in his or her opinion, interfere with the
ability and capacity of the couple to care for a child throughout childhood;
and
(c) a
statutory declaration signed by both spouses, stating—
(i)
that neither spouse is, as at the date of the signing of
the declaration, subject to a term of imprisonment in this State or elsewhere
or to outstanding charges (whether in this State or elsewhere) for an offence
for which imprisonment may be imposed on conviction; and
(ii)
that neither spouse has been found guilty, in this State
or elsewhere, of a sexual offence involving a child; and
(iia)
whether either spouse has been found guilty, in this State or elsewhere, of an
offence involving violence; and
(iii)
whether either spouse has had a child permanently removed
from his or her guardianship under any Act or law of this State or any other
place (other than by adoption).
(1a) If a statutory
declaration under subclause (1)(c) reveals that either spouse—
(a) is
subject to a term of imprisonment in this State or elsewhere or to outstanding
charges (whether in this State or elsewhere) for an offence for which
imprisonment may be imposed on conviction; or
(b) has
been found guilty, in this State or elsewhere, of a sexual offence involving a
child,
the licensee must not give infertility treatment to the person (or to the
other spouse).
(1b) If a statutory
declaration under subclause (1)(c) reveals that either spouse has been
found guilty, in this State or elsewhere, of an offence involving violence
(other than an offence within the ambit of subclause (1a)), the licensee
must not give infertility treatment to the person (or to the other spouse)
unless or until the review panel approves the provision of the treatment.
(1c) If a statutory
declaration under subclause (1)(c) reveals that either spouse has had a
child permanently removed from his or her guardianship under any Act or law of
this State or any other place (other than by adoption), the licensee must
refer the matter to the Child Protection Services unit of the Women's and
Children's Hospital or the Flinders Medical Centre and must not give
infertility treatment to the person (or to the other spouse) unless or until a
clinician within the unit approves the provision of the treatment.
(2) A licensee must
not give or continue to give infertility treatment, or cause, suffer or permit
infertility treatment to be given or continued, to a married couple if—
(a) the
licensee is satisfied that any of the information contained in a letter of
referral or statutory declaration referred to in subclause (1) is false;
or
(b) the
licensee is satisfied that, since the signing of the statutory declaration
referred to in subclause (1)(c)—
(i)
either spouse has become ill, or is suffering from a
disease or disability, and the licensee is of the opinion that the illness,
disease or disability will interfere with the ability and capacity of the
couple to care for a child throughout childhood; or
(ii)
either spouse has commenced serving a term of
imprisonment in this State or elsewhere; or
(iii)
either spouse has been charged (whether in this State or
elsewhere) with an offence for which imprisonment may be imposed on conviction
and the charge has not been finally dealt with by a court or otherwise
disposed of; or
(iv)
either spouse has been found guilty, in this State or
elsewhere, of a sexual offence involving a child; or
(v)
either spouse has been found guilty, in this State or
elsewhere, of an offence involving violence; or
(vi)
either spouse has had a child permanently removed from
his or her guardianship under any Act or law of this State or any other place
(other than by adoption).
(3) In a case where
subclause (2)(b)(v) applies (and the relevant offence does not fall
within the ambit of subclause (2)(b)(ii), (iii) or (iv)), the licensee
must not give or continue to give infertility treatment to the relevant couple
without the approval of the review panel.
(3a) In a case where
subclause (2)(b)(vi) applies, the licensee must not give or continue to
give infertility treatment to the relevant couple without the approval of a
clinician within the Child Protection Services unit of—
(a) the
Women's and Children's Hospital facility of the Children, Youth and Women's
Health Service Incorporated; or
(b) the
Flinders Medical Centre facility of the Southern Adelaide Health Service
Incorporated.
(3b) If a matter is
referred under subclause (1c) or (3a), a clinician within the relevant
unit must undertake an assessment of the couple's parenting skills and an
approval must not be given under the relevant subclause unless the clinician
is satisfied that there is a reasonable likelihood of the couple being able to
care properly for, and nurture, a child throughout childhood.
(4) A licensee must
not give infertility treatment, or cause, suffer or permit infertility
treatment to be given, to a married couple unless the licensee is
satisfied—
(a) that
the couple has received adequate counselling from a medical practitioner or a
counsellor regarding—
(i)
the paramount importance of the welfare of any child that
may be born in consequence of infertility treatment; and
(ii)
the stress factors involved in the treatment; and
(b) that
the couple has received adequate counselling from a medical practitioner
regarding—
(i)
the medical or surgical procedures involved in the
treatment; and
(ii)
the risks involved in the treatment; and
(iii)
the likelihood of the various possible outcomes of the
treatment; and
(c) that
the husband and wife have been adequately informed by a medical practitioner
or counsellor of—
(i)
current knowledge and research about the psychological
and physical outcomes of infertility treatment for children born in
consequence of the application of artificial fertilisation procedures; and
(ii)
where the couple is to receive infertility treatment
involving the use of donor reproductive material—
(A) current opinion on the disclosure to
children born in consequence of the use of donor reproductive material of the
circumstances of their conception and the implications of secrecy on family
relationships; and
(B) the right under this code of persons of
or over the age of 16 who were born in consequence of the use of donor
reproductive material to obtain access to non-identifying information about
the donor or donors; and
(C) the availability of practical advice on
what, when and how to disclose to children born in consequence of the use of
donor reproductive material the circumstances of their conception; and
(d)
where the couple is to receive infertility treatment involving the use of
donor reproductive material and the licensee knows or has reason to believe
that the identity of the donor is known to one or both spouses—
(i)
that the couple have received adequate information from a
medical practitioner or counsellor regarding the law of this State relating to
the parentage of children born in consequence of the use of donor reproductive
material; and
(ii)
that the donor has received adequate counselling from a
medical practitioner or counsellor regarding the paramount importance of the
welfare of any child that may be born in consequence of infertility treatment.
(5) If a licensee
refuses to give infertility treatment to a married couple—
(a) on
the ground that the licensee does not provide a form of treatment that meets
the particular medical needs of the couple; or
(b) on
the ground that the couple are unable to afford the cost of treatment,
the licensee must provide the couple with the name and address of such other
licensee or licensees as he or she believes can—
(c)
offer a form of treatment that may meet the medical needs of the couple; or
(d)
provide treatment at a cost that the couple may be able to afford,
as the case may require.
(6) A licensee who
refuses to give or to continue to give infertility treatment to a married
couple must—
(a) on
request by the couple, give the couple written reasons for the refusal; and
(b)
where relevant, give the couple written information about the processes
associated with the initiation of proceedings before the review panel.
12—Eligibility for donation of reproductive material
(1) A licensee must
not accept the donation of reproductive material from any person unless—
(a) the
prospective donor has been screened in accordance with the Fertility Society
donor screening guidelines; and
(b) the
prospective donor has signed a lifestyle declaration in the form set out in
the Fertility Society Code of Practice and furnished it to the licensee; and
(c) the
prospective donor has received adequate information from a medical
practitioner or counsellor regarding the law of this State relating to the
parentage of children born in consequence of the use of donor reproductive
material; and
(d) the
prospective donor has been informed by a medical practitioner or counsellor
that if it comes to the knowledge of the licensee that a child born in
consequence of the use of the donor's reproductive material has been diagnosed
as suffering from a hereditary illness or disease, the licensee will give the
donor a written notice setting out the matters referred to in
clause 44(2)(a) to (c) and advising of the availability of counselling.
(2) A licensee must
not accept the donation of reproductive material from any person if, after
screening of the prospective donor in accordance with subclause (1)(a),
the licensee has reason to believe that the prospective donor is or may be
suffering from an illness, disease or genetic defect or trait for which the
screening was carried out.
(3) A licensee must
provide a prospective donor of reproductive material who signs a lifestyle
declaration with a copy of the declaration.
13—Welfare of child to be paramount consideration of licensee
A licensee must, in deciding whether or not to give infertility treatment to
any person, or to accept the donation of reproductive material from any person
for use in infertility treatment, treat the welfare of any child that may be
born in consequence of the treatment as the paramount consideration.
14—Licensee's discretion to refuse treatment
The provisions of this Part do not restrict a licensee's discretion to refuse
to give or to continue to give infertility treatment to a person on any
reasonable ground.
(1) The Minister must
appoint a review panel for the purposes of this Part.
(2) The review panel
will consist of five members, of whom—
(a) one
(the presiding member) will be a legal practitioner; and
(b) one
will be a member of the Council; and
(c) one
will be a social worker, nurse or clinical psychologist who has experience in
the field of child welfare; and
(d) one
will be a person with expertise in the rehabilitation of persons who have
committed offences involving violence; and
(e) one
will be a person appointed to represent the interests of consumers of
infertility treatment services.
(2a) The Minister may
appoint a suitable person to be a deputy of a member of the panel and the
deputy may act as a member of the panel in the absence or during a temporary
vacancy in the office of that member.
(3) A member of the
panel will be appointed for a term not exceeding three years on such
conditions as the Minister may determine and will, at the expiration of a term
of office, be eligible for reappointment.
(4) A person ceases to
be a member of a panel if the person—
(a)
resigns by notice in writing addressed to the Minister; or
(b) is
removed from the panel by the Minister on the ground of misconduct, neglect of
duty, incompetence or mental or physical incapacity to carry out official
duties; or
(c) has
completed a term of office and is not reappointed to the panel.
(1) Proceedings before
the review panel for the purposes of this Part must be initiated in a manner
and form determined by the review panel.
(2) The purpose of any
proceedings is to review the circumstances surrounding the offence or offences
that have given rise to the proceedings before the review panel, and for the
review panel to assess whether the welfare of any child born as a result of
infertility treatment might be compromised on account of the commission of the
offence or offences, and whether a licensee should be able to consider
offering infertility treatment despite the offence or offences.
(1) For the purposes
of this Part—
(a)
proceedings before the review panel must be held without formality and in
private; and
(b) the
review panel is not bound by the rules of evidence, but may inform itself on
any matter in such manner as the panel thinks fit.
(2) On proceedings
before the review panel the licensee and the married couple may be assisted by
an agent or representative (not being a legal practitioner).
(3) A decision of four
members of the review panel is a decision of the panel.
(5) The review panel
must give the licensee and married couple written reasons for the panel's
decision under this Part.
(1) A licensee or
married couple aggrieved by a decision of the review panel under this Part
may, in accordance with the rules of court, appeal to the Supreme Court
against the decision.
(2) An appeal must be
instituted within one month of the making of the decision being appealed
against but the Court may, if it is satisfied that it is just and reasonable
in the circumstances to do so, dispense with the requirement that the appeal
be instituted within that period.
(3) On an appeal under
this clause, the Court may—
(a)
confirm the decision under appeal or set aside the decision;
(b) make
any further or other order as to any other matter that the case requires.
14E—Welfare of child to be paramount consideration on review or appeal
The review panel or Supreme Court must, in making a determination under this
Part, treat the welfare of any child that may be born in consequence of
infertility treatment given to the married couple as the paramount
consideration.
Part 4—Consent
Division 1—Consent to infertility treatment
(1) A licensee must
not give infertility treatment or cause, suffer or permit infertility
treatment to be given to any person unless the person and the spouse of that
person have consented to the treatment in accordance with this Part.
(2) A consent to
infertility treatment involving the use of an in vitro fertilisation procedure
or gamete intra fallopian transfer procedure is effective—
(a) for
three cycles of such treatment; or
(b) for
12 months,
whichever first occurs.
(3) A consent to
infertility treatment involving an artificial insemination by donor procedure
is effective—
(a) for
six cycles of such treatment; or
(b) for
12 months,
whichever first occurs.
Division 2—Consent to collection of donor ova
16—Consent to collection of donor ova
A licensee must not enter into any arrangement with a woman for the donation
of her ova unless she has consented in accordance with this Part to the
carrying out of any medical or surgical procedure (including the use of drugs)
that will be associated with the removal of the ova from her body.
Division 3—Consent to storage and use of reproductive material
17—Consent to storage of gametes
A licensee must not keep semen or ova in storage or cause, suffer or permit
semen or ova to be kept in storage unless—
(a) the
person on whose behalf the semen or ova is to be stored; and
(b) if
that person is not the person who produced the semen or ova—the donor of
the sperm or ova,
has consented in accordance with this Part to the storage.
18—Consent to storage of embryos
(1) Subject to
clause 26(2), a licensee must not keep an embryo in storage for the
future use of a married couple, or cause, suffer or permit an embryo to be
kept in storage for that purpose unless both the husband and the wife have
consented in accordance with this Part to the storage.
(2) Consent to storage
of an embryo may be given subject to conditions as to how the embryo is to be
dealt with or disposed of.
19—Review of consent to storage of embryos
(1) A person on whose
behalf an embryo is kept in storage by a licensee has (while the embryo
remains in storage) the right to review the consent at intervals of 12 months.
(2) A licensee who
keeps an embryo in storage on behalf of a married couple must, at least 90
days before each anniversary of the date on which consent to the storage was
given, give the husband and the wife written notice informing them of their
right to review their consent and inviting them to exercise that right.
20—Consent to use of gametes and embryos
A licensee must not use reproductive material, or cause, suffer or permit
reproductive material to be used, for any purpose unless the person or persons
who produced the material has or have consented in accordance with this Part
to the use of the material for that purpose.
21—Consent to use in infertility treatment of embryos used in research
A licensee must not, in giving infertility treatment to a married couple, use,
or cause, suffer or permit to be used, an embryo that has been used in
research unless both the husband and the wife have consented in accordance
with this Part to the use of that embryo in their infertility treatment.
Division 4—Consent to disclosure of confidential information
22—Consent to disclosure of confidential information
For the purposes of section 18(1)(c) of the Act and clause 36 of this
code, the provisions of clause 23 apply in relation to the giving of
consent by a person to the disclosure of information concerning himself or
herself.
Division 5—General provisions
(1) For the purposes
of this code, a consent—
(a) must
be given in writing in a manner and form that complies with the Reproductive
Technology (Consent Forms) Standard 1995 prepared by the Council, as in
force from time to time; and
(b) will
not be regarded as effective unless—
(i)
in the case of consent to infertility treatment, the
married couple giving consent has, before signing the consent form,
received—
(A) the counselling referred to in
clause 11(4); and
(B) an information statement that complies
with the Reproductive Technology (Information Statements) Standard 1995
prepared by the Council, as in force from time to time; or
(ii)
in the case of consent to the donation of reproductive
material—
(A) the prospective donor has, before
signing the consent form, received an information statement that complies with
the Reproductive Technology (Information Statements) Standard 1995
prepared by the Council, as in force from time to time; and
(B) where the licensee knows or has reason
to believe that the identity of the prospective donor is known to one or both
of the spouses for whose benefit reproductive material of the donor is to be
used—the prospective donor has, before signing the consent form,
received the counselling referred to in clause 11(4)(d); and
(c) may
be given subject to conditions; and
(d) may
be varied at any time by the signatories by notice in writing given to the
licensee; and
(e) may
be revoked at any time by a signatory by notice in writing given to the
licensee.
(2) A licensee must
not, without lawful excuse, contravene or fail to comply with any condition of
a consent given under this Part.
24—Licensee to provide copy of consent form
A licensee must provide a person who gives consent under this Part with a copy
of any consent form signed by the person.
25—Licensee to dispose of stored donor gametes in certain cases
A licensee must dispose of donor semen or ova kept in storage if consent to
the storage or use of the semen or ova is revoked by the donor in accordance
with this Part.
26—Licensee to dispose of stored embryo in certain cases
(1) A licensee must
dispose of an embryo that is kept in storage for the future use of a married
couple if—
(a) the
licensee becomes aware that the husband or wife has died or that their
marriage has been dissolved; or
(b) the
consent to the storage of the embryo is revoked in accordance with this Part
by the husband or wife, or both.
(2) Subclause (1)
does not apply where the conditions of a consent given under clause 18
specify how an embryo is to be dealt with or disposed of in the event that one
or both of the spouses die, their marriage is dissolved or one or both of them
become incapable of reviewing their consent, in which case the licensee must
deal with the embryo or dispose of it in accordance with those conditions.
27—Effect of this Part on other laws
The provisions of this Part are in addition to the requirements of any other
laws relating to obtaining informed consent to the carrying out of medical or
surgical procedures.
Part 5—Records
Division 1—Records relating to recipients of infertility treatment
(1) A licensee must
establish a record in relation to a married couple to whom the licensee is to
give infertility treatment.
(2) The record must
contain the following information:
(a) such
information of a personal and medical nature concerning each of the spouses as
good medical practice requires;
(b) full
particulars of the couple's eligibility under the Act and this code for
infertility treatment;
(c) in
relation to counselling received by the couple pursuant to
clause 11—
(i)
the full name, business address and professional
qualifications of the counsellor;
(ii)
the dates on which the counselling was given;
(d) full
particulars of any consent given by the couple under Part 4;
(e) a
short summary (including the date on which it occurred) of any consultation
with the couple in relation to the selection of the source of donor
reproductive material to be used for the benefit of the couple;
(f) a
short summary (including the date on which it occurred) of any consultation
with an embryologist in relation to the use, in the couple's infertility
treatment, of an embryo that has been used in research;
(g) in
relation to infertility treatment given to the couple by the licensee—
(i)
the numbers of cycles of treatment completed;
(ii)
in relation to any drugs prescribed or administered
during treatment—
(A) the name of the drug;
(B) the dosage prescribed or administered;
(C) the purpose for which the drug was
prescribed or administered;
(iii)
particulars of any medical or surgical procedures carried
out;
(iv)
the name of the person or persons who carried out those
procedures;
(v)
the results of any laboratory tests performed to monitor
responses to treatment;
(vi)
if infertility treatment is discontinued by the licensee,
the reasons for the discontinuance;
(vii)
in relation to any artificial fertilisation procedure
resulting in the fertilisation of one or more ova—
(A) the nature of the procedure carried
out;
(B) the time and date on which the
procedure was carried out;
(C) the place at which the procedure was
carried out;
(D) the name of the person or persons who
carried out the procedure;
(E) whether sperm of the husband or a donor
was used in the procedure;
(F) whether ova of the wife or a donor were
used in the procedure;
(G) the number of ova fertilised;
(H) if one or more fertilised ova were
placed in the body of the wife immediately after fertilisation, the number of
fertilised ova so placed;
(I) if any fertilised ova were not placed
in the body of the wife immediately after fertilisation, whether, and how
many, fertilised ova were put into storage, disposed of or used for some
purpose other than in the treatment of the couple;
(h) the
outcome of each pregnancy established in consequence of infertility treatment
given by the licensee;
(i)
in relation to each child born in consequence of
infertility treatment given to the couple by the licensee—
(i)
such information of a personal and medical nature
concerning the child as good obstetric practice requires;
(ii)
full particulars of the child's state of health at the
age of 28 days;
(j) such
other information as the couple request to be included in the record.
(3) Where a licensee
carries out an artificial fertilisation procedure in consequence of which a
pregnancy is established using donor reproductive material donated to the
licensee, the licensee must ensure that the record kept by the licensee under
this code in relation to the married couple for whose benefit the pregnancy
was established is cross-referenced to the record kept by the licensee under
this code in relation to the donor.
(4) For the purposes
of subclause (3), a licensee must cross-reference information by means of
a code to which only the licensee and persons employed and authorised by the
licensee have access.
(1) A licensee must,
on application in writing by a married couple in relation to whom a record is
kept by the licensee under this Division, provide the couple with a copy of
the record.
(2) A licensee must,
on application in writing by a person to whom the licensee is giving or has
given infertility treatment, provide the person with a copy of such portions
of the record kept by the licensee under this Division as relate solely to the
person.
(3) Where donor
reproductive material has been used for the benefit of a married couple and a
child has been born in consequence of that use, the licensee to whom the
reproductive material was donated must, on application by the donor, provide
the donor with a copy of all non-identifying information kept by the licensee
under this Division in relation to the couple.
(4) A licensee to whom
reproductive material is donated must, on application by the donor, inform him
or her of the number and sex of children (if any) born in consequence of the
use of his or her reproductive material.
Division 2—Records relating to donors of reproductive material
(1) A licensee who
accepts the donation of reproductive material must establish a record in
relation to the donor.
(2) The record must
contain the following information:
(a) the
date of birth, country of birth, racial origin, nationality, religion,
educational history, occupation, marital status, number of children and
leisure interests of the donor;
(b) the
donor's sex, height, weight, eye colour, hair colour and skin colour;
(c) full
particulars of the medical history of the donor and of his or her parents;
(d) such
particulars as the donor provides of any known hereditary illness or disease
of the donor's grandparents, great grandparents, brothers, sisters and
children;
(e) the
donor's assessment of his or her personality;
(f) the
reasons given by the donor for donating reproductive material;
(g) full
particulars of any payment to the donor for the disbursement of expenses
incurred by the donor in connection with his or her donation of reproductive
material;
(h) full
particulars of any consent given by the donor under Part 4;
(i)
in relation to the reproductive material—
(i)
the date on which it was collected;
(ii)
the time and place at which it was collected;
(iii)
in the case of the donation of ova, the name of the
person or persons who performed any procedures associated with the collection
of the ova;
(j) such
other information as the donor requests to be included in the record.
(3) A licensee must
ensure that identifying information relating to a donor of reproductive
material is kept separate from all other information concerning the donor.
(1) A licensee must,
on application in writing by a donor of reproductive material in relation to
whom a record is kept by the licensee under this Division, provide the donor
with a copy of the record.
(2) Subject to
subclause (3), a licensee must, on application by a person of or over the
age of 16 years who was born in consequence of the use of donor reproductive
material, give to the person a copy of all information (other than identifying
information) relating to the donor or donors kept by the licensee under this
code.
(3) Where the licensee
has reason to believe that, if all or some of that information were disclosed
to the applicant, there may, in the circumstances of the particular case, be a
reasonable likelihood of the donor's identity thereby being readily
ascertainable, the licensee must not disclose that information.
Division 3—Other records
32—Records to be kept relating to reproductive material
A licensee must establish and maintain detailed records relating to the
collection, storage, use and disposal of reproductive material by the
licensee.
33—Records to be kept of clinical standards and procedures
A licensee must establish and maintain detailed records relating to all
clinical and laboratory standards and procedures used by the licensee in the
provision of infertility treatment services.
34—Record to be kept of criteria for use of certain embryos in
infertility treatment
A licensee must keep a record of the criteria used by the licensee for
determining whether embryos that have been used in research are suitable for
use in infertility treatment.
Division 4—General provisions
(1) A licensee must
ensure that such steps are taken as are necessary to ensure that any
confidential information kept by the licensee under this code is disclosed
only as is authorised or required by the Act and this code.
(2) Where a licensee
has reasonable grounds for suspecting that confidential information kept by
the licensee under this code has been disclosed in contravention of the Act or
this code, the licensee must as soon as practicable—
(a)
cause an investigation of the matter to be carried out; and
(b)
cause a written report of the results of the investigation to be prepared and
submitted to the Minister.
(3) If, in the course
or in consequence of the investigation, the licensee is satisfied that there
are reasonable grounds to suspect that a person has committed an offence
against the Act, the licensee must immediately report the matter to the
Commissioner of Police.
36—Access to personal information
(1) Subject to
subclause (2), where—
(a)
application is made to a licensee for access to information concerning the
personal affairs of a person in relation to whom the licensee keeps a record
under this code; and
(b) the
person to whom the information relates has given his or her consent in
accordance with Part 4 to disclosure of the information,
the licensee must give the applicant a copy of that information.
(2) A licensee must
not disclose the identity of a donor of reproductive material to a person who
was born in consequence of the use of the donor's reproductive material unless
the person is of or over the age of 16 years.
A licensee must preserve a copy of the following documents for at least 50
years from the date on which they were received by the licensee:
(a) any
document furnished to the licensee under Part 3; and
(b) any
consent given to the licensee under Part 4.
38—Period for which records must be preserved
(1) Subject to
subclause (2), a licensee must preserve a record kept by the licensee
under this Part for 50 years from the date on which the last entry was made in
the record.
(2) Where no
pregnancies have been established as a result of the use of a donor's
reproductive material, a licensee who keeps a record relating to the donor
under this Part must preserve the record for seven years from the date on
which the last entry was made in the record.
A licensee must take reasonable steps to ensure that all records kept by the
licensee under this code are at all times complete and accurate.
40—Amendment of personal records
A licensee must, on application by a recipient of infertility treatment or a
donor of reproductive material in relation to whom the licensee keeps a record
under this code, make such amendments to the record as are requested by the
applicant unless the licensee has reason to believe that the requested
amendments would result in the record being incomplete, inaccurate or
misleading.
Part 6—Miscellaneous
41—Medical practitioner to be assigned to recipients of infertility
treatment
A licensee must not give infertility treatment, or cause, suffer or permit
infertility treatment to be given, to a married couple unless the licensee has
first assigned a medical practitioner to be primarily responsible for the
management of the couple's treatment.
42—Licensee to select donor gametes to be used in particular cases
A licensee must not, in giving infertility treatment to a married couple, use,
or cause, suffer or permit to be used, any donor reproductive material unless
the source of the material to be used for that couple has been selected in
consultation with the couple by the licensee or a person authorised by the
licensee.
43—Licensee to notify child or parents of any hereditary illness etc of
donor
(1) Where—
(a) a
child is born in consequence of the use of donor reproductive material by a
licensee; and
(b) it
comes to the knowledge of the licensee that, since the birth of the child, the
donor, or some other child of whom the donor is a biological parent, has been
diagnosed by a medical practitioner as suffering from a hereditary illness or
disease,
the licensee must obtain the opinion of a medical practitioner with expertise
in the field of genetics as to—
(c) the
likely effects of the hereditary illness or disease on the health and life
expectancy of a person suffering from the illness or disease; and
(d) the
likelihood of the child referred to in paragraph (a) developing the
hereditary illness or disease.
(2) The licensee must,
as soon as practicable after receipt of the opinion, give a written notice
that complies with this clause—
(a) if
the child is of or over the age of 16 years—to the child;
(b) if
the child is under the age of 16 years—to his or her parents.
(3) A notice under
this clause must—
(a)
specify that the donor or child of whom the donor is a biological parent has
been diagnosed by a medical practitioner as suffering from a hereditary
illness or disease and set out the nature of the illness or disease; and
(b)
explain the likely effects of the illness or disease on the health and life
expectancy of a person suffering from the illness or disease; and
(c)
specify the likelihood of the child referred to in subclause (1)(a)
developing the hereditary illness or disease; and
(d)
specify the names and addresses of counsellors who may be available to provide
counselling.
44—Licensee to notify gamete donor of hereditary illness etc of
biological child of donor
(1) Where—
(a) a
child is born in consequence of the use of donor reproductive material; and
(b) it
comes to the knowledge of the licensee to whom the reproductive material was
donated that the child has been diagnosed by a medical practitioner as
suffering from a hereditary illness or disease,
that licensee must obtain the opinion of a medical practitioner with expertise
in the field of genetics as to—
(c) the
likely effects of the hereditary illness or disease on the health and life
expectancy of a person suffering from the illness or disease; and
(d) the
likelihood of the donor developing the hereditary illness or disease.
(2) The licensee must,
as soon as practicable after receipt of the opinion, give the donor a written
notice that—
(a)
specifies that a child of whom the donor is a biological parent has been
diagnosed by a medical practitioner as suffering from a hereditary illness or
disease and set out the nature of the illness or disease; and
(b)
explains the likely effects of the illness or disease on the health and life
expectancy of a person suffering from the illness or disease; and
(c)
specifies the likelihood of the donor developing the hereditary illness or
disease; and
(d)
specifies the names and addresses of counsellors who may be available to
provide counselling.
45—Availability of Act and regulations for inspection
A licensee must ensure that a copy of the Act, any regulations made under the
Act (including this code) and any standard or code of practice adopted by or
referred to in such regulations are kept available for inspection by any
interested person.
(1) A licensee must,
not later than 28 February in each year, furnish to the Council a report
relating to such matters as the Council may determine by written notice given
to the licensee.
(2) In making a
determination for the purposes of subclause (1), the Council must take
into account any relevant requirements or guidelines imposed or published by
the NHMRC with respect to the regulation of reproductive technology, and may
take into account such other matters as the Council thinks fit.
47—Notification of accreditation status to Council
(1) A licensee must,
at least once every three years, give the Council written notice of the status
of the licensee's accreditation by the Reproductive Technology Accreditation
Committee of the Fertility Society of Australia to carry out artificial
fertilisation procedures.
(2) A notice under
subclause (1) must be accompanied by the relevant letters, certificates
or other written evidence of the accreditation.
(3) A licensee must,
as soon as practicable after any change in the licensee's accreditation status
becomes known to the licensee, give the Council a written notice setting out
full details of the change.
48—Notification of birth defects
A licensee must, as soon as practicable after becoming aware that a child born
in consequence of infertility treatment given by the licensee is suffering
from any birth defect, give the Pregnancy Outcome Unit of the Department of
Human Services written notice of the birth defect, specifying the nature of
the defect.
A notice or document required or authorised by this code to be given to a
person may be given personally or posted to the person's last known address.